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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K050507
Device Name SMARTECH, MODEL HOLI I
Applicant
Cycling and Health Tech. Industry R&D Center
# 17, 37th Rd.,
Taichung Industry Park
Taichung,  TW 40768
Applicant Contact CHANG WAN-LAN
Correspondent
Cycling and Health Tech. Industry R&D Center
# 17, 37th Rd.,
Taichung Industry Park
Taichung,  TW 40768
Correspondent Contact CHANG WAN-LAN
Regulation Number890.3800
Classification Product Code
INI  
Date Received02/28/2005
Decision Date 07/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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